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PubMed2003

Electroconvulsive therapy for the depressed elderly.

BACKGROUND: Depressive disorder is a common mental disorder in old age, with serious health consequences such as increased morbidity, disability, and mortality. The frailty of elderly may seriously hamper the efficacy and safety of pharmacotherapy in depressed elderly. Electroconvulsive therapy (ECT) in depressed elderly therefore may be an alternative to treatment with antidepressants. OBJECTIVES: To assess the efficacy and safety of ECT (compared to simulated ECT or antidepressants) in depressed elderly. SEARCH STRATEGY: We searched the CCDANCTR database, Medline 1966-2000, EMBase 1980-2000, Biological abstracts 1985-2000, Cinahl 1982-2000, Lilacs from 1982 onwards, Psyclit 1887-2000, Sigle 1980-2000. The reference lists of relevant papers were scanned for published reports. Hand searching of the Journal of ECT and the Journal of Geriatric Psychiatry was done. Based on the title of the publication and its abstract, non-eligible citations were excluded. SELECTION CRITERIA: Data were independently extracted by at least two reviewers. Randomised, controlled trials on depressed elderly (> 60 years) with or without concomitant with conditions like cerebrovascular disease, dementia of the Alzheimer's type, vascular dementia or Parkinson's disease were included. DATA COLLECTION AND ANALYSIS: Data were independently extracted by at least two reviewers. For continuous data weighted mean differences (WMD) between groups were calculated. MAIN RESULTS: Randomised evidence is sparse. Only three trials could be included, one on the efficacy of real ECT versus simulated ECT (O'Leary et al 1994), one on the efficacy of unilateral versus bilateral ECT (Fraser 1980) and the other comparing the efficacy of ECT once a week with ECT three times weekly (Kellner 1992). All had major methodological shortcomings; data were mostly lacking essential information to perform a quantitative analysis. Although the O'Leary study concluded that real ECT was superior over simulated ECT, these conclusions need to be interpreted cautiously. Only results from the second trial (unilateral versus bilateral ECT) could be analysed, not convincingly showing efficacy of unilateral ECT over bilateral ECT, WMD 6.06 (CI -5.20,17.32). Randomised evidence on the efficacy and safety of ECT in depressed elderly with concomitant dementia, cerebrovascular disorders or Parkinson's disease is completely lacking. Possible side-effects could not be adequately examined because the lack of randomised evidence and the methodological shortcomings. REVIEWER'S CONCLUSIONS: None of the objectives of this review could be adequately tested because of the lack of firm, randomised evidence. Given the specific problems in the treatment of depressed elderly, it is of importance to conduct a well designed randomised controlled trial in which the efficacy of ECT is compared to one or more antidepressants.

Aged↗
PubMed2005

Non-invasive positive pressure ventilation for treatment of respiratory failure due to severe acute exacerbations of asthma.

BACKGROUND: Non-invasive positive pressure ventilation (NPPV) has been shown to be effective in chronic obstructive pulmonary disease (COPD) patients with acute respiratory failure. However, its role in patients with severe acute asthma is uncertain. The pathophysiologic condition of acute respiratory failure in asthma is in many ways similar to that of acute respiratory failure in COPD. Therefore, there is reason to believe that NPPV could also be successful in patients with severe acute asthma. OBJECTIVES: To determine the efficacy of NPPV in adults with severe acute asthma, in comparison to usual medical care, with respect to mortality, tracheal intubation, changes in blood gases, and hospital length of stay. SEARCH STRATEGY: An initial search for studies was carried out using the Cochrane Controlled Trials Register (CENTRAL). Additional searches were carried out on MEDLINE, EMBASE, CINAHL, Science Citation and web based clinical trials databases. Key journals with web sites were also searched as well as respiratory conference proceedings. Following this, the bibliographies of each randomised controlled trial obtained (and any review articles) were searched for additional studies. The date of the most recent search for trials was May 2004. SELECTION CRITERIA: All data were analysed using RevMan. For continuous variables a weighted mean difference and 95% confidence interval (95% CI) was calculated for each study outcome. For dichotomous variables relative risk with 95% confidence interval was calculated. DATA COLLECTION AND ANALYSIS: All data was analysed using RevMan. For continuous variables, a weighted mean difference and 95% confidence interval (95%CI) was calculated for each study outcome. For dichotomous variables relative risk with 95% confidence interval was calculated. MAIN RESULTS: From an initial search of 696 abstracts, 11 trials were obtained in full text for closer examination. Ten trials were excluded and one included. The one included trial, on 30 patients, showed benefit with NPPV when compared to usual medical care alone, with significant improvements in hospitalisation rate, number of patients discharged from emergency department, percent predicted forced expiratory volume in one minute (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and respiratory rate. AUTHORS' CONCLUSIONS: The application of NPPV in patients suffering from status asthmaticus, despite some interesting and very promising preliminary results, still remains controversial. Large, prospective randomised controlled trials are therefore needed to determine the role of NPPV in status asthmaticus.

Acute Disease↗
PubMed2001

Effectiveness of acupuncture for stroke: a systematic review.

BACKGROUND: Acupuncture has been suggested as a treatment for stroke rehabilitation, but the question whether it is effective has not been answered satisfactorily. PURPOSE: To summarise and critically review all randomised controlled trials of the effectiveness of acupuncture as a treatment for stroke. METHODS: Four independent computerised literature searches (in MEDLINE, Cochrane Controlled Trials Register, Embase, and CISCOM data bases) were conducted in June 1999. All randomised-controlled trials that compared any form of needle insertion acupuncture to any form of non-acupuncture control intervention in the treatment of human stroke patients were included. Data were extracted independently by two authors and arbitrated by a third. The methodological quality of the included studies was assessed using the Jadad score. RESULTS: Nine randomised controlled trials with a total sample size of 538 patients were included. Two studies were assessor blind, one was subject blind, and one was assessor and subject blind. Two studies exclusively used manual acupuncture, five only electroacupuncture, and two used both. Outcome measures used were Scandinavian Stroke Scale, Chinese Stroke Scale or Recovery Scale, Barthel index, Nottingham Health Profile, Motor function, balance, and days in hospital. Of the nine studies, six yielded a positive result suggesting that acupuncture is effective, and three produced a negative finding implying that acupuncture is not superior to control treatment. Only two studies obtained a Jadad score of more than 3. These methodologically best trials showed no significant effect of acupuncture. CONCLUSION: Based on the evidence of rigorous randomised controlled trials, there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation. Further, better-designed studies are warranted.

Acupuncture Therapy↗
PubMed2005

Effectiveness of extracorporeal shock wave therapy for tennis elbow (lateral epicondylitis).

Randomised controlled trials were reviewed to evaluate the evidence of the effectiveness of extracorporeal shock wave therapy in the management of tennis elbow. Seven relevant trials were found, which had satisfactory methodology but conflicting results. Further research with well designed randomised control trials is needed to establish the absolute and relative effectiveness of this intervention for tennis elbow.

Adolescent↗
PubMed2005

Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme.

OBJECTIVE: To evaluate a training intervention aimed at improving healthcare professionals' communication with cancer patients about randomised clinical trials. DESIGN: Before and after evaluation of training programme. SETTING: Members of the National Cancer Research Network, Scottish Trials Network, and the Welsh Cancer Trials Network. PARTICIPANTS: 101 healthcare professionals (33 clinicians and 68 research nurses). INTERVENTION: Four modules delivered by a trained facilitator using videotapes and interactive exercises to cover general issues about discussing randomised clinical trials with patients, problems specific to adjuvant trials, trials with palliation as the goal, and trials where patients had a strong preference for one treatment arm. MAIN OUTCOME MEASURES: Before and after the intervention, participants were videotaped discussing a trial with an actor portraying a patient. These consultations were assessed for presence of information required by good clinical practice guidelines. The actor patients gave an assessment after each interview. Participants reported their self confidence about key aspects of trial discussion. RESULTS: Analysis of the videotaped consultations showed that, after intervention, significantly more participants displayed key communication behaviours such as explaining randomisation (69 v 81, odds ratio 2.33, P = 0.033), checking patients' understanding (11 v 31, odds ratio 3.22, P = 0.002), and discussing standard treatment (73 v 88, odds ratio 4.75, P = 0.005) and side effects (69 v 85, odds ratio 3.29, P = 0.006). Participants' self confidence increased significantly (P < 0.001) across all areas. Actor patients' ratings of participants' communication showed significant improvements for 12/15 key items. CONCLUSION: This intensive 8 hour intervention significantly improved participants' confidence and competence when communicating about randomised clinical trials.

Clinical Competence↗
PubMed1998

Heparin in acute ischaemic stroke. The T wave is negative and it's time to stop.

The use of heparin for acute ischaemic stroke has long been controversial. Although it may have some theoretical benefits in preventing fibrin formation and thrombus propagation, data from 16 randomised controlled trials involving more than 22,000 patients show that heparin produces no significant net benefit in eventual outcome.

Acute Disease↗
PubMed2002

[Screening for bronchial carcinoma].

Bronchial carcinoma is the principal cause of cancer death. Unlike cancers of the breast and colon that are already the subject of screening programmes, proof has not yet been provided that screening for bronchial carcinoma is of value in terms of reduction in mortality. Technological improvements and the advent of low dose spiral CT scanning has lead to a recent renewal of interest in this subject. The first preliminary studies seem to indicate that 2/3 of bronchial carcinomas discovered by CT scanning are detected at an early stage. Other data suggest a possible improvement in survival of tumours discovered by screening. Nevertheless it is necessary to demonstrate that screening improves the survival of patients with bronchial carcinoma. The present consensus does not advocate mass screening by CT scanning but that high risk subjects should voluntarily participate in randomised controlled trials which alone will confirm or refute the validity of this approach.

Aged↗
PubMed1985

Povidone-iodine bowel irrigation before resection of colorectal carcinoma.

Preoperative mechanical bowel preparation, peroperative topical antiseptic measures, and postoperative antibiotic therapy have all been shown to reduce infection after colorectal surgery. We report the results of a randomised trial of preoperative irrigation with a 10% aqueous solution of povidone-iodine (Betadine) versus water in patients undergoing major resection for large bowel carcinoma. All patients had mechanical bowel preparation, preoperative topical povidone-iodine and per and postoperative antibiotics. Of 22 study patients only one (4.6%) developed abdominal wound infection, whereas in 23 controls nine (39.1%) did so (P less than 0.01). In three of the study patients cultures of swabs taken at operation from the transected bowel ends showed no bacterial growth. Arguably the bacterial population would have been markedly reduced in other patients. These results suggest that povidone-iodine irrigation before large bowel resection reduces wound sepsis.

Aged↗
PubMed2002

Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.

OBJECTIVE: To assess the association between competing interests and authors' conclusions in randomised clinical trials. DESIGN: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. STUDIES: 159 trials from 12 medical specialties. MAIN OUTCOME MEASURES: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. RESULTS: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. CONCLUSIONS: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.

Analysis of Variance↗
PubMed2003

Parent-mediated early intervention for young children with autism spectrum disorder.

BACKGROUND: Recent estimates concerning the prevalence of autistic spectrum disorder are much higher than those reported 30 years ago, with at least 1 in 400 children affected. This group of children and families have important service needs. The involvement of parents in implementing intervention strategies designed to help their autistic children has long been accepted as helpful. The potential benefits are increased skills and reduced stress for parents as well as children. OBJECTIVES: The objective of this review was to determine the extent to which parent-mediated early intervention has been shown to be effective in the treatment of children aged 1 year to 6 years 11 months with autistic spectrum disorder. In particular, it aimed to assess the effectiveness of such interventions in terms of the benefits for both children and their parents. SEARCH STRATEGY: A range of psychological, educational and biomedical databases were searched. Bibliographies and reference lists of key articles were searched, field experts were contacted and key journals were hand searched. SELECTION CRITERIA: Only randomised or quasi-randomised studies were included. Study interventions had a significant focus on parent-implemented early intervention, compared to a group of children who received no treatment, a waiting list group or a different form of intervention. There was at least one objective, child related outcome measure. DATA COLLECTION AND ANALYSIS: Appraisal of the methodological quality of included studies was carried out independently by two reviewers. Differences between the included studies in terms of the type of intervention, the comparison groups used and the outcome measures were too great to allow for direct comparison. MAIN RESULTS: The results of this review are based on data from two studies. Two significant results were found to favour parent training in one study: child language and maternal knowledge of autism. In the other, intensive intervention (involving parents, but primarily delivered by professionals) was associated with better child outcomes on direct measurement than were found for parent-mediated early intervention, but no differences were found in relation to measures of parent and teacher perceptions of skills and behaviours. REVIEWER'S CONCLUSIONS: This review has little to offer in the way of implications for practice: there were only two studies, the numbers of participants included were small, and the two studies could not be compared directly to one another. In terms of research, randomised controlled trials involving large samples need to be carried out, involving both short and long-term outcome information and full economic evaluations. Research in this area is hampered by barriers to randomisation, such as availability of equivalent services.

Autistic Disorder↗
PubMed2005

Understanding randomised controlled trials.

The hierarchy of evidence in assessing the effectiveness of interventions or treatments is explained, and the gold standard for evaluating the effectiveness of interventions, the randomised controlled trial, is discussed. Issues that need to be considered during the critical appraisal of randomised controlled trials, such as assessing the validity of trial methodology and the magnitude and precision of the treatment effect, and deciding on the applicability of research results, are discussed. Important terminologies such as randomisation, allocation concealment, blinding, intention to treat, p values, and confidence intervals are explained.

Child↗
PubMed2005

Intracoronary brachytherapy--clinical state and pathophysiological considerations.

In-stent restenosis remains the limitation of coronary stent implantation despite numerous efforts of its prevention by catheter-based techniques or by drug therapy. Today, only intravascular irradiation has proven to effectively reduce neointima formation, restenosis rate and major adverse cardiovascular events by approximately 50%. Its efficiency is demonstrated for high-risk subsets like long lesions, lesions in saphenous venous bypass grafts or diabetic patients, indicating the extraordinary potential of vascular irradiation. Yet vascular irradiation has some limitations. Edge effect describes the phenomenon of excessive neointimal proliferation at the edges of an irradiated segment and is likely due to axial dose fall-off and/ or barotrauma by the angioplasty procedure. Geographic miss, the combination of dose fall-off and vessel injury may be deleterious, especially if a new stent is implanted. The use of appropriate radiation source lengths to avoid geographic miss substantially reduces the incidence of edge effect. Late thrombosis, occurring even years after irradiation, had significantly diminished the benefit of vascular irradiation in initial clinical trials, but extension of ntiplatelet therapy up to 12 months after irradiation has reduced its rates to placebo levels. Vascular brachytherapy is of considerable clinical benefit in the prevention of restenosis and the only proven option for the treatment of in-stent restenotic lesions. This review will focus on the mechanisms of action of vascular irradiation, on the pathophysiological reasons for its complications and therapeutic options. Both angiographic and clinical results of randomised and observational studies will be updated in detail.

Brachytherapy↗
PubMedDate not supplied

[Drug evaluation methods in lower limb arteriopathy].

The prevalence and severity of chronic vascular leg disease explains the necessity to clarify methods for assessing it. Today the methods are both clinical and paraclinical. Clinically, they are based on the Fontaine and Leriche classification and appearance of ischaemic pain. Paraclinically, they are measuring distal blood pressure, artery output, micro-circulation, rheology, and tissular metabolism. But this approach must be also global, assessing coronary and carotid disease. Trials methodology includes a first step of explanatory studies by paraclinical ways and lastly pragmatic efficacy and tolerability studies. We recommend an accurate selection of patients and a stratification. The disease must be stable and the treatment and diet too. The trials should be randomised vs placebo. In conclusion we propose a multiparametric classification of the disease.

Amputation, Surgical↗
PubMed2003

Immunotherapy for IgM anti-Myelin-Associated Glycoprotein paraprotein-associated peripheral neuropathies.

BACKGROUND: Serum monoclonal anti-Myelin Associated Glycoprotein antibodies may be pathogenic in some patients with IgM paraprotein and demyelinating neuropathy. Immunotherapies aimed at reducing the level of these antibodies might be expected to be of benefit in the treatment of the neuropathy. Many potential therapies have been described in small trials, uncontrolled studies and case reports. OBJECTIVES: To examine the efficacy of any form of immunotherapy in reducing disability and impairment resulting from IgM anti-Myelin Associated Glycoprotein paraprotein-associated demyelinating peripheral neuropathy. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group register (August 2002) and MEDLINE (January 1966 - August 2002) and EMBASE (January 1980 - August 2002) for controlled trials, checked the bibliographies to identify other controlled trials and contacted authors and other experts in the field. SELECTION CRITERIA: Types of studies: randomised or quasi-randomised controlled trials. TYPES OF PARTICIPANTS: patients of any age with anti-Myelin Associated Glycoprotein antibody associated demyelinating peripheral neuropathy with monoclonal gammopathy of undetermined significance of any severity. Types of interventions: any type of immunotherapy. Types of outcome measures: Primary: improvement in the Neuropathy Disability Score or Modified Rankin Scale six months after randomisation Secondary: Neuropathy Disability Score and/or the Modified Rankin Score 12 months after randomisation. Ten metre walk time, subjective clinical scores and electrophysiological parameters at six and 12 months after randomisation. IgM paraprotein levels and anti-Myelin Associated Glycoprotein antibody titres six months after randomisation. Adverse effects of treatments. DATA COLLECTION AND ANALYSIS: We identified six randomised controlled trials of which five were included after discussion between the authors. One author extracted the data and the other checked them. No missing data could be obtained from authors. MAIN RESULTS: The five eligible trials used four of the many available immunotherapy treatments. Only two had comparable interventions and outcomes but these were only short-term studies. There were no significant benefits of the treatments used in the predefined outcomes. However intravenous immunoglobulin showed benefits in terms of improved Modified Rankin Scale at two weeks and 10 metre walk time at four weeks. Serious adverse effects of intravenous immunoglobulin are known to occur from observational studies but none were encountered in these trials. REVIEWER'S CONCLUSIONS: There is inadequate reliable evidence from trials of immunotherapies in anti-Myelin Associated Glycoprotein paraproteinaemic neuropathy to recommend any particular immunotherapy treatment. Intravenous immunoglobulin is relatively safe and may produce some short-term benefit. Large well designed randomised trials are required to assess the efficacy of promising new therapies.

Demyelinating Diseases↗
PubMed2004

Progestogens in combined oral contraceptives for contraception.

BACKGROUND: The progestogen component of oral contraceptives (OC) has undergone changes since it was first recognised that their chemical structures could influence the spectrum of minor adverse and beneficial effects. The major determinants of OCs are effectiveness, cycle control and common side effects. The rationale of this review is to provide a systematic comparison of OCs containing the progestogens currently in use worldwide. OBJECTIVES: The objective of this review is to compare currently available low-dose OCs containing ethinyl estradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE and EMBASE databases have been searched systematically. Relevant pharmaceutical companies and the authors of articles included in this review have been contacted for clarification. SELECTION CRITERIA: Randomised trials reporting clinical outcomes were considered for inclusion. We excluded studies comparing mono- with multiphasic pills, and crossover trials with trials in which the difference in total content of ethinyl estradiol between preparations exceeded 105 micro g. DATA COLLECTION AND ANALYSIS: The methodological quality and validity of studies were assessed based on the above-mentioned inclusion criteria. Both application of inclusion criteria and data extraction were performed independently by the reviewers. Results are expressed as relative risk (RR) with 95% confidence interval (CI) using a random-effects model. MAIN RESULTS: Twenty-two trials have been included in this review, thus generating 14 comparisons. Eighteen trials were sponsored by pharmaceutical companies and in only 5 cases had a blind trial been attempted. Most comparisons between different interventions included 1-3 trials. There was less discontinuation with second- compared to first-generation progestogens (RR: 0.79, 95% CI: 0.69-0.91). Cycle control appears to be better when using second- compared to first-generation progestogens for both mono- (RR: 0.69; 95% CI: 0.52-0.91) and triphasic (RR: 0.61; 95% CI: 0.43-0.85) preparations.Contraceptive effectiveness, spotting, breakthrough bleeding and the absence of withdrawal bleeding was similar when using GSD compared to LNG, although there was less intermenstrual bleeding in the GSD group (RR: 0.71, 95% CI: 0.55, 0.91). Drospirenone (DRSP) appeared to be similar to DSG. REVIEWERS' CONCLUSIONS: Based on data from one trial, compared to pills containing LNG, those containing GSD may be associated with less intermenstrual bleeding although they show similar patterns of spotting, breakthrough bleeding and the absence of withdrawal bleeds. GSD is also comparable to DSG. Regarding acceptability, all the indices show that third- and second-generation progestogens are preferred over first-generation preparations. Future research should focus on independently conducted, well-designed randomised trials that compare third- and second-generation progestogens in particular.

Contraception↗
PubMed1999

The Cochrane Collaboration.

The Cochrane Collaboration is an international organisation that aims to help people make well-informed decisions about health care by preparing, maintaining and ensuring the accessibility of systematic reviews of the benefits and risks of health care interventions. We describe the structure and activities of the Cochrane Collaboration, especially focusing on the carrying out of systematic reviews of randomised trials. We describe the place of surgery and surgeons within the Cochrane Collaboration.

Evidence-Based Medicine↗
PubMed1998

The interpretation of clinical trials of immediate versus delayed therapy.

Prospective, randomised clinical comparisons with a control group are the ideal way to evaluate the effectiveness of a new therapy. However if the new therapy is already available, then it may be unethical to refuse patients this treatment indefinitely. In some trials, patients randomised to the control group receive placebo until their condition deteriorates, and are then switched to the new therapy. Patients randomised to the experimental group receive the new treatment immediately. An analysis following the intention-to-treat principle will be a valid comparison of the two treatment policies actually used. However, such an analysis will underestimate the effect of immediate therapy relative to completely untreated controls, and in particular a negative conclusion should not be interpreted to mean that the therapy is ineffective. In this paper we introduce a parametric approach, which models the dependence between the survival time and the time of switching to the new treatment. This is used first to illustrate the lack of power of the intention-to-treat analysis for evaluating the therapy relative to a pure control. More speculatively, an alternative method of analysis based on our model is presented. We illustrate the issues with data from a prospective randomised study, in which one group of HIV-positive patients received zidovudine immediately after randomisation while control patients were switched to zidovudine only when their condition deteriorated.

Anti-HIV Agents↗